Wednesday, December 8, 2010

Sunovion Offers Psychiatrists Free Trips to Miami to Promote Latuda

Talk about chutzpah. You'd think that after all the recent revelations of psychiatrists selling themselves out to the highest bidders, a drug company would think twice before waving wads of cash in front of their faces. And you’d hope that the psychiatrists would be slightly reluctant leap up and grab the loot.

Not so on both counts. Sunovion, maker of the latest atypical antipsychotic to be approved by the FDA, Latuda (Lurasidone), recently sent out a round of emails to psychiatrists offering free winter trips to Miami, Dallas and Scottsdale.

Oddly, I was one of the recipients—and in order to find out more details I played investigative journalist, pretending I was interested in the offer. Here’s what I found out.

I received the first e-mail on November 4, 2010:

“On behalf of Sunovion Pharmaceuticals Inc., Health and Wellness Partners (HWP) is pleased to invite you to participate in a Latuda® (lurasidone HCI) tablets Speakers’ Bureau Meeting entitled A New Atypical Antipsychotic Agent for the Treatment of Schizophrenia. The purpose of the Speaker Training Meetings is to train and educate psychiatrists about Latuda and schizophrenia, who in turn will educate other health care professionals in peer to peer meetings....If you wish to attend the meeting, please click the button below to proceed to the registration page where you will indicate your first, second and third choices for date/location by November 8, 2010. Registration will be on a first come, first served basis so please be sure to register early.”

For some background on Latuda, see my earlier post in which I briefly reviewed the pros and cons of the drug. Essentially, it appears to be as effective as most antipsychotics, less effective than Zyprexa, causes little if any weight gain or metabolic problems (just like Abilify, Fanapt, Geodon, and Trilafon), but causes plenty of troublesome side effects like sedation and a severe form of restlessness called akathisia. Since it provides no clear advantages over existing options, why don't we just re-name the drug “Metooda.”

At any rate, I went ahead and started the online registration process, and immediately received the following:

“Thank you for completing the Save the Date for the Speaker Training Meeting. To initiate the process and your Speaker Agreement, please forward a copy of your CV immediately. You can e-mail it to registration@hwpnj.com or fax it to 201-661-5580. Since registration is on a first come, first served basis, we urge you to respond quickly…. Please indicate your preference of first, second and third choice of which meeting you would like to attend.:

Friday, December 10 – Saturday, December 11, 2010 in Miami, FL,

Friday, January 7 – Saturday, January 8, 2011 in Dallas, TX,

Friday, January 14 – Saturday, January 15, 2011 in Scottsdale, AZ”

While I had no intention of actually going to any of these tempting locales (at least not on their dime), I chose Miami in the hopes of getting the ball rolling more quickly. A week later, on November 11, I got this response:

“On behalf of Sunovion Pharmaceuticals Inc., we are pleased to confirm your participation in the Latuda® (lurasidone HCI) tablets Speakers' Bureau Meeting, A New Atypical Antipsychotic Agent for the Treatment of Schizophrenia on Friday, December 10 - Saturday, December 11, 2010 in Miami, FL.We will be sending you additional registration details shortly.If you have any questions regarding the meeting, please contact Health and Wellness Partners at registration@hwpnj.com, or call 551-579-6980. Your call will be returned within 24 hours.”

But then, on November 23, my dreams of a pharma-funded junket were quashed:

“Dear Doctor:

Thank you for your interest in the LATUDA (lurasidone HCl) tablets Speakers’ Bureau Meeting. Due to the overwhelming response to this meeting the registration site unfortunately accepted more registrants than there were spots available, and we are unable to accept your registration at this time. We apologize for any inconvenience this may have caused you, and again, thank you for your interest.”

Of course, I have no way of knowing if I was rejected because they finally googled me, or because there truly was an "overwhelming response." If they were telling me the truth, I suppose I should not be surprised, since according to the largest existing database of hired guns by ProPublica, psychiatrists top the lists of doctors vying for drug company cash (see Medscape's coverage of this dubious distinction here). If they were lying, my feeling’s aren’t hurt, particularly since I myself was being sneaky in pretending that I was interested in taking them up on their offer.

At any rate, over the next few weeks, I’m sure I’ll hear more from various colleagues about how lavish the resorts are, about the amount of the “honorarium” that goes along with the trip (I’m guessing around $1500), and about whether these doctors have to promise to actually do anything in return for the trip. In the past, speaker’s bureau meetings were little more than bribes to get doctors to listen to “key opinion leaders” expound on a new drug. The return on that investment could then be measured by local drug reps using prescription data-mining technology.

As befits a me-too drug, Sunovion is using the same old me-too strategies to manipulate medical opinion. Cash, pools, and room service work every time.

11 comments:

Anonymous
said...

Chutzpah, indeed.

I should point out that in my area, even though Latuda has not yet been promoted, I do know that Sunovion has been extremely aggressive in contacting doctors to give talks (not me, unfortunately, darn I would like a trip to Scottsdale right about now), and they've also made a great effort to attract the most experienced local drug reps to their sales force.

Judging by the differences I've observed between this product roll-out and the recent introductions of Fanapt, Saphris, and Invega, Sunovion either has a HUGELY effective agent that will revolutionize mental health care, or they're trying to "buy" that perception.

Thanks, Dr Carlat, for helping to clarify which conclusion is more plausible.

You can almost see the PR machine unfolding. A literature search for "lurasidone" yields 8 articles, including 3 reviews and 2 animal studies. Three of the articles are co-authored by Antony Loebel, formerly of UCSD (where he has co-authored articles with Stahl) and currently employed by Sunovion.

The 2 animal studies (both by the Dainippon group, developers of lurasidone) studied the effects of lurasidone on its ability to overcome a memory impairment induced by dizocilpine (an NMDA antagonist) as measured by behavioral tasks. How this correlates to cognitive dysfunction in human schizophrenics is not described.

One of the papers by Loebel describes the validation of a cognitive battery (the MCCB) which will apparently be used to measure improvements in cognitive function in lurasidone trials. (Nothing was said about any improvement due to lurasidone in the 3 weeks in which this study was performed.)

And, of course, there's a Stahl article in J Clin Psych (Nov 2010, right on time!) describing how 5-HT7 agents "may" be helpful for "antidepressant and memory-enhancing actions."

So let's see:

Improvement in an animal model of "memory impairment"? Check.

Association between lurasidone and a "cognitive battery" (even though no data)? Check.

What's really sad is that there is no good treatment for negative symptoms. Once in a blue moon clozapine seems to work miracles, more often than not, it does nothing. And aside from clozapine...There is NO GOOD TREATMENT for schizophrenia. That's what the real tragedy is.

Dr. John does make sense. It's sort of like a free trip to the Poconos to listen to a time-share spiel. I mean what the heck? You don't have to drink the Kool Aid just because Sunovion fronts a trip for you to Miami.

And re: "Essentially, it appears to be as effective as most antipsychotics, less effective than Zyprexa, causes little if any weight gain or metabolic problems..."

Neurological and metabolic car wrecks accumulate all the time with psychotropics after FDA approval. See the inexorably increasing inventory of crashed and burned victims of Cymbalta via a web query. Thousands have gotten pulverized by that drug. But the FDA continues to maintain that Cymbalta is just swell because Lilly games what study results it reports out.

So Doc, what makes you think Latuda will escape the same eventual realization of a crapped out side effect profile? BTW, if you do a search at the FDA ClinicalTrials.gov site on "Lurasidone" AND "Studies With Results" you get ZERO hits.

From a patient's point of view, I wholeheartedly agree. But from my experience, I also think that the old antipsychotics are under-utilized.

I currently take one atypical and one old antipsychotic and I've never been this stable, even on Clozaril. I don't understand what is so taboo about them and why doctors spend so much time going through failed trials of atypicals and don't consider adding an old antipsychotic.

I'm not a doctor, and I'm basing my argument completely on my experience, but I've been doing so much better it's just hard for me to ignore the value of the addition of an old antipsychotic to my atypical.

They are shaping a cognitive battery to be sensitive to the benefit profile of this drug. There is a history of over 100 years of cognitive testing; what has a psychiatrist and a drug company figured out that the neuropsychologists not yet figured out in the recent 100 years?

Myself, if you let me assess a stroke patient, I will pinpoint the location as well as medical imaging will. Plus, for the money, I can describe the functional impairments that should be expected.

I am not a neuropsychologist, just well-trained and aware of what the state of the art is in neuropsychology. That is why I wonder how this cogntive test might have improved on what exists already.

My thoughts exactly. I looked at the MATRICS study by Keefe et al -- the paper that demonstrated its reliability & validity in a trial of lurasidone vs risperidone (but which reported no actual data showing how patients responded to each drug).

The MCCB is a battery of several existing neuropsychological tests, which takes 75-90 minutes to administer. It was developed by a multidisciplinary team including academics & scientists from Lilly, Merck, and Sanofi. (Details are at www.matrics.ucla.edu)

I'm not a neuropsychiatrist, but it seems that the MCCB provides a comprehensive assessment of several cognitive domains. It does not seem to have been designed to be "sensitive to the benefit profile" of lurasidone. Nevertheless, it is a research tool and probably has little direct clinical applicability.

If lurasidone is shown to have a significant benefit relative to risperidone across the board on all MCCB measures, I will be impressed. However, I can also envision two other possibilities: (a) lurasidone shows benefit on only a subset of tests or (b) all antipsychotics show improvement on the MCCB, not just lurasidone.

It would be interesting to see what Sunovion reveals to the participants of these meetings, since none of the relevant data have been published (and probably won't be until Latuda's release). After all, the meetings are for "Speakers," not everyday psychiatrists, so, to your point, I would imagine the spin will be heavy.

Is anyone besides me scratching their head over the name of this drug? Latuda? Sounds like something out of a Rap song. Lurasidone to Latuda? I think the marketing department fell short on the name of this one.

I would like to respond to those doctors who have (hopefully) been joking around about taking the trip just to stick it to The (Pharma) Man. There are at least 2 very big reasons you may want to reconsider this idea:

1. You will add needless expense to the healthcare system. There are many who believe you are already doing this by prescribing expensive drugs to people who do not need them, but whose circumstances have been medicalized by your profession in order that they might be billed successfully for your services.

2. The drug companies most likely will report publicly that you were paid an honorarium and given this junket. You do, indeed, have patients who will see these reports. Upon seeing these reports, said patients will see your names and, not knowing that it was all just a joke and that you did not attend any meetings or do any speaking, they will instantly lose respect for, faith in and trust in you.

If you want to screw pharma for your own enjoyment, there are better ways. Stop seeing reps. Stop accepting samples. Stop writing for ineffective drugs. Never use a brand name as a first-line drug unless there is no other reasonable option. Go to the AMA's website and request that the AMA not sell your information so that pharma cannot track your prescribing habits and adjust their tactics accordingly. Write letters to the editors of the journals and professional magazines/newspapers you read explaining your thoughts on DTC advertising and drug ads to YOU in their journals, etc... as well as detailing how you feel when you find out about yet another psychiatric drug that has buried, falsified or otherwise tainted data. These are reasonable, non-childish ways of sticking it to The Pharma Man.